9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System

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• 作者：Donald E. Cutlip ; MD^a ; ^{dcutlip@bidmc.harvard.edu} ; Kirk N. Garratt ; MD^b ; Victor Novack ; MD ; PhD^c ; Mark Barakat ; MD^d ; Perwaiz Meraj ; MD^e ; Luc Maillard ; MD ; PhD^f ; Andrejs Erglis ; MD^g ; Rajiv Jauhar ; MD^e ; Jeffrey J. Popma ; MD^a ; Robert Stoler ; MD^h ; Sigmund Silber ; MDⁱ ; for the PzF SHIELD Trial InvestigatorsDonald Cutlip ; Suhail Allaqaband ; Ronald Caputo ; Nirat Beohar ; David Brown ; Kirk Garratt ; Rajiv Jauhar ; Jon George ; Vincent Varghese ; Mark Huth ; German Larrain ; Tommy Lee ; Amir Malik ; Scott Martin ; Thomas McGarry ; Charles Phillips ; Alpesh Shah ; Robert Stoler ; Michael Ball ; R. Jeffrey Price ; Joseph Rossi ; Charles Taylor ; Thaddeus Tolleson ; William Nicholson ; Srinivas Kesanakurthy ; Mohammad Shoukfeh ; Aloke Finn ; Chandanreddy Devireddy ; Charles Shoultz ; Mark Robbins ; Radoslaw Kiesz ; Pramod Menon ; Daniel Weilenmann ; Horst Sievert ; Andrejs Erglis ; Goran Stankovic ; Jacques Berland ; Nicolas Delarche ; Jean Lou Hirsch ; Luc Maillard ; John Shayne ; Antonio Serra ; Antonio Fernandez-Ortiz ; Jean-Pierre Monassier ; Sigmund Silber
• 关键词：restenosis ; stent(s) ; thrombosis
• 刊名：JACC: Cardiovascular Interventions
• 出版年：2017
• 出版时间：23 January 2017
• 年：2017
• 卷：10
• 期：2
• 页码：160-167
• 全文大小：418 K
• 卷排序：10

文摘

The aim of this study was to assess the safety and effectiveness of the COBRA Polyzene-F NanoCoated Coronary Stent System (CeloNova Biosciences, San Antonio, Texas) for the treatment of de novo coronary artery lesions.BackgroundPolyzene-F–coated coronary stents have shown reduced thrombogenicity and inflammation in preclinical studies.MethodsPatients with de novo coronary artery lesions meeting eligibility criteria were enrolled in a nonrandomized, prospective clinical trial. The primary endpoint was target vessel failure (TVF) (defined as a composite of cardiac death, myocardial infarction, or clinically driven target vessel revascularization) at 9 months. A pre-specified subset was planned for routine repeat angiographic follow-up at 9 months. The powered secondary endpoint was mean late lumen loss (LL). The comparator was a performance goal derived from meta-analysis of historical bare-metal stent trials of 19.62% for TVF and 1.1 mm for LL. Other secondary endpoints were clinically driven target lesion revascularization and definite or probable stent thrombosis.ResultsOf 296 enrolled patients, 287 (97%) completed primary endpoint analysis; 130 were planned for angiographic follow-up and 115 (88%) completed. At 9 months, TVF had occurred in 33 patients (11.5%; upper 95% confidence boundary: 15.07%), including 1 (0.3%) cardiac death, 20 (7.0%) myocardial infarctions (17 periprocedural), and 17 (5.9%) target vessel revascularizations. LL was 0.84 ± 0.48 mm (upper 95% confidence boundary: 0.92). Target lesion revascularization occurred in 13 patients (4.6%). There were no stent thrombosis events.ConclusionsThe COBRA Polyzene-F stent met performance goals for TVF and LL at 9 months. There was an excellent safety profile, with infrequent late myocardial infarction and no stent thrombosis.